TVAC - Disposable portable suction unit - TYTEK MEDICAL INC.

Duns Number:078589992

Device Description: Disposable portable suction unit

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More Product Details

Catalog Number

TM-909

Brand Name

TVAC

Version/Model Number

TM-909

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

BSY

Product Code Name

Catheters, Suction, Tracheobronchial

Device Record Status

Public Device Record Key

25f2425b-a690-48c2-bc71-d497cc79233b

Public Version Date

October 11, 2019

Public Version Number

1

DI Record Publish Date

October 03, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"TYTEK MEDICAL INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 10